Onco Actu du 4 juin 2019 - spécial ASCO

	5.5.1 ASCO (GÉNÉRAL)
At cancer conference, debate over speedy drug approvals in the spotlight [Biopharma Dive] "[Accelerated approval] won't work all the time — we know that — and in this case it unfortunately didn't," said Dickler at a plenary discussion session Sunday, estimating that Lilly had spent roughly $200 million on the ANNOUNCE study.
	5.5.10 ASCO (HÉMATO)
ASCO: J&J eyes Darzalex convenience, safety boost with subcutaneous win [Fierce Pharma] And without skimping on efficacy, subcutaneous Darzalex recorded a big win, too. Only 12.7% of patients receiving the subcutaneous drug experienced infusion-related side effects—a big drop from the 34.5% of patients in the control group who reported them.
IMBRUVICA® (ibrutinib) Long-Term Data from Two Pivotal Phase 3 Studies at ASCO and EHA Demonstrate Sustained Efficacy and Safety in Patients with Chronic Lymphocytic Leukemia (CLL) [Janssen] Five-year follow-up data from the RESONATE-2 study showed sustained progression-free survival benefit in patients with previously untreated CLL receiving IMBRUVICA monotherapy versus chlorambucil, with an estimated overall survival rate of 83 percent reported in patients treated with IMBRUVICA.
J&J, Genmab strengthen case for Darzalex in frontline multiple myeloma with fresh slate of PhIII data [EndPoints] As J&J and Genmab await a decision on their sBLA in September, Sanofi has a foot in US and EU regulators’ door for isatuximab’s first approval.
Seattle Genetics Announces Additional Analyses of ECHELON-1 and ECHELON-2 Phase 3 Clinical Trials of ADCETRIS® (Brentuximab Vedotin) at the 2019 ASCO Annual Meeting [Seattle Genetics] Three-Year Update of ECHELON-1 Trial Continues to Demonstrate Superior Clinical Activity of ADCETRIS in Combination with Chemotherapy when Compared to ABVD in Frontline Hodgkin Lymphoma.
	5.5.13 ASCO (DIVERS)
Without older subjects, cancer drugs trials rely on atypical patients [Reuters] “We found that the age disparities in enrollment of elderly patients, which are pervasive in clinical trials in cancer, seem to be worsening. And these disparities are particularly pronounced among trials funded by industry.”
Fitbits prescribed to cancer patients could boost survival rates, research suggests [The Telegraph] Speaking at the American Society of Clinical Oncology’s annual conference, in Chicago, doctors said wearables were set to become a standard part of treatment in future, with 70 clinical trials now underway.
A Plea For A Focus On The Humanity Of Cancer Care: Are We Missing An Opportunity When It Comes To Artificial Intelligence? [Dr. Len] Wouldn’t it be great if technology could help us to become human again? That, my friends, would be intelligent—and not artificial.
	5.5.13.3 ASCO (DIVERS-CHIRURGIE)
Colorectal Cancer Patients With Liver Metastases Live Just as Long After Laparoscopic Surgery as Open Surgery [ASCO] Overall, patients lived more than 6.5 years after surgery, regardless of whether it was laparoscopic or open.
	5.5.14 ASCO (VESSIE)
Yale Cancer Center researchers show novel drug increased survival for bladder cancer patients [Yale Cancer Center] The researchers now are proceeding with a phase III randomized trial that will compare enfortumab vedotin (EV) against standard chemotherapy for this patient population.
ASCO: Astellas, Seattle Genetics' ADC banishes 12% of bladder cancers [Fierce Biotech] Going earlier might allow for the elimination of the most toxic chemo drug or drugs from a patient’s regimen, or even to drop chemo altogether. But that will come after approval in relapsed patients. Astellas and Seattle Genetics are preparing an FDA submission, which they hope to file before the year is out.
Novel Targeted-Antibody Treatment Produced Responses in Nearly Half of Patients With Advanced Urothelial Cancer [ASCO] A single arm, phase II clinical trial of 125 patients showed treatment with enfortumab vedotin (EV) – a new agent targeting Nectin-4, a protein found in 97% of urothelial cancers – produced responses in 44% of patients with locally advanced or metastatic forms of urothelial cancer. Patients had previously been treated with platinum chemotherapy and a PD-1 or PD-L1 immune checkpoint inhibitor, but the cancer had progressed despite these treatments.
#ASCO19: Clay Siegall is ready to take a big leap forward as Seattle Genetics’ next top drug prospect steps onto center stage at ASCO [EndPoints] Siegall also wants badly to move this drug into the frontline setting, and has three studies underway — in combination with pembro and a combo with chemo as well as a triplet with pembro and chemo.
Seattle Genetics and Astellas Announce Antibody-Drug Conjugate Enfortumab Vedotin Produced Tumor Response Rate of 44 Percent in Patients with Most Common Type of Advanced Urothelial (Bladder) Cancer [Seattle Genetics] First Investigational Therapy in a Pivotal Trial to Address Unmet Need for Patients with Advanced Urothelial Cancer After Treatment with Platinum Chemotherapy and a PD-1 or PD-L1 Inhibitor.
Seattle Genetics, Astellas drug rapidly shrinks tumors in bladder cancer study [Reuters] In the 125-patient study of the drug, enfortumab vedotin, the overall response rate was 44%, meaning tumors were at least 30% smaller for those patients. That included a complete response, or no detectable cancer, for 12% of patients.
	5.5.15 ASCO (BIOPSIES LIQUIDES)
Grail's Newest Early Cancer Detection Data Lays Path for Return of Results Next Year [Genome Web] An open question for the Grail data (and for similar reports from competitors) is whether the sensitivity numbers seen in these initial case-control analyses will hold true in prospective analyses of the intended population, in this case individuals without a known cancer.
	5.5.16.1 ASCO (MÉDECINE DE PRÉCISION-TRK/RET)
Blueprint keeps pressure on Lilly with RET-targeted cancer therapy [Biopharma Dive] Acquired resistance is always a concern with targeted therapy, as tumors morph in response to treatment. Blueprint's data offered some reassurance on that front, with responses still ongoing in more than half of those whose tumors had shrunk.
New data on larotrectinib efficacy in patients with TRK fusion cancer and primary CNS tumors or brain metastases presented at ASCO 2019 [Bayer] In 14 adult and pediatric patients with TRK fusion cancer with primary central nervous system (CNS) tumors (including high grade gliomas), the overall response rate was 36% including two complete responses.
Blueprint Medicines' Highly Selective RET Inhibitor BLU-667 Shows Durable Anti-Tumor Activity in Patients with RET-Altered Cancers in Updated ARROW Trial Data Presented at ASCO 2019 [Blueprint Medicines] 60% ORR in post-platinum RET-fusion NSCLC and 63% ORR in RET-mutant MTC patients previously treated with multi-kinase inhibitors; median durations of response not reached.
Larotrectinib, first targeted therapy for childhood solid tumours, shown to be effective [Gustave Roussy] Concomitantly, the results of the MAPPYACTS international trial, also presented at ASCO and led by Gustave Roussy in France, Ireland and Italy, show that sequencing of tumours in children in relapse or with treatment failure can lead to the identification of young patients likely to benefit from Larotrectinib treatment.
	5.5.16.3 ASCO (MÉDECINE DE PRÉCISION-KRAS)
ASCO: Amgen's closely watched KRAS drug, first to clinic, shrinks NSCLC, curbs colorectal tumors [Fierce Biotech] The study enrolled 35 patients with advanced KRAS-mutated cancers: 14 with NSCLC, 19 with colorectal cancer and two with cancer of the appendix.
Early cancer drug data give Amgen hope it has 'cracked KRAS code' [Biopharma Dive] Amgen's drug, called AMG 510, is the first of its kind to reach clinical testing. It works by binding to what the company describes as a "hidden groove" on the protein produced by the mutated KRAS gene. With AMG 510 locked on, the protein is inactivated, in theory shutting down the signals it sends to trigger cell division and tumor growth.
#ASCO19: Amgen grows more confident in KRAS G12C drug with a positive snapshot for lung cancer — shares spike [EndPoints] Growing more confident, Amgen’s team now is looking to get this drug into more patients, adding a combo with a PD-1 — I found out this weekend that Amgen has their own in development, though it may not be in play here — and “firing up” a pivotal Phase II as quickly as the FDA will permit.
Amgen Announces First Clinical Data Evaluating Novel Investigational KRASG12C Inhibitor AMG 510 At ASCO 2019 [Amgen] AMG 510 is the First KRASG12C Inhibitor to Reach Clinical Stage After Three Decades of RAS Research.
Amgen drug shows high response rate in small lung and colon cancer trial [Reuters] Wall Street has taken a keen interest in the Amgen drug, which could become the first approved medicine targeting a mutated form of a gene known as KRAS - one of the most common mutations found in non-small cell lung cancer (NSCLC).
	5.5.2 ASCO (SEIN)
Hortobagyi honored by ASCO for his work against breast cancer [MD Anderson Cancer Center] Hortobagyi developed, implemented, and chaired the MONALEESA-2 phase III trial, assessing the efficacy and safety of ribociclib in combination with letrozole in patients with hormone receptor-positive metastatic breast cancer. Overall survival data on that trial was highlighted Saturday morning at ASCO.
	5.5.4 ASCO (IMMUNOTHÉRAPIES)
New head and neck cancer drug could help patients live longer [The Guardian] Pembrolizumab with platinum chemotherapy less ‘aggressive’ and extended survival rates.
ASCO 2019: Immunotherapy better than aggressive chemotherapy as first treatment option for recurrent head and neck cancer [Institute of Cancer Research] The new clinical trial results offer strong evidence in favour of pembrolizumab, either on its own or in combination with chemotherapy, becoming the first treatment of choice for people with head and neck cancer that has come back and spread.
	5.5.4.5 ASCO (IMMUNOTHÉRAPIES-CAR-T, THÉRAPIES CELLULAIRES)
ASCO: Gilead touts CAR-T franchise with Yescarta analyses, early data on pipeline drug [Fierce Pharma] Gilead also rolled out a new Yescarta safety analysis Monday showing that using steroids soon after Yescarta treatment could help manage cytokine release syndromes and other serious side effects associated with chimeric antigen receptor T-cell (CAR-T) drugs.
	5.5.6 ASCO (PEAU-MÉLANOME)
ASCO: Complete response rate in Nektar melanoma trial hits 34% [Fierce Biotech] Nektar thinks its data mark a new high for complete responses in melanoma and sees scope for the figure to rise further still. Four patients remain on treatment and have responses that could deepen.
Five-Year Survival Observed in Longest Follow-up to Date of Advanced Melanoma Patients Treated with the Combination of Opdivo (nivolumab) and Yervoy (ipilimumab) [BMS] Five-year follow-up analysis from Phase 1 CA209-004 study provides evidence of long-term survival following discontinuation of treatment in patients with advanced melanoma; Analyses from Phase 3 CheckMate -067 study provide new long-term quality of life data on Opdivo alone and in combination with Yervoy.
	5.5.7 ASCO (GYNÉCO)
Lynparza achieved a 72% objective response rate in patients with relapsed, germline BRCA-mutated advanced ovarian cancer [AstraZeneca] Based on results in the Phase III SOLO3 trial, Lynparza is the first and only PARP inhibitor to demonstrate efficacy vs. chemotherapy.
Over 60 Percent of Gynecologic Oncologists Say They Have Experienced Sexual Harassment [ASCO] A recent survey of U.S.-based physician members of the Society of Gynecologic Oncology found that 64% of respondents experienced sexual harassment in training or practice; among women, the rate was 71% and among men it was 51%. Only 10% reported the incident(s) to officials.
	5.5.8 ASCO (POUMON)
Novartis Shows Growing Strength in Lung Cancer Innovation with New Capmatinib Investigational Data and Novel Canakinumab Clinical Trials [Novartis] The U.S. Food and Drug Administration (FDA) recently granted capmatinib Breakthrough Therapy Designation for the treatment of patients with metastatic NSCLC harboring MET exon-14 skipping mutation with disease progression on or after platinum-based chemotherapy; discussions with global health authorities are underway.
Takeda Presents Results from Lung Portfolio Including Phase 1/2 Study of TAK-788 in a Rare Form of NSCLC and New Data on Overall Health-Related Quality of Life for ALUNBRIG® (brigatinib) [Takeda] Phase 1/2 Data Being Presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting Demonstrated TAK-788 Extended the Time Until Disease Progression or Death by More Than Seven Months.
Use of Broader Criteria for Clinical Trial Enrollment Would Double Number of Eligible Patients With Lung Cancer [ASCO] A study looking at 10,500 health records of advanced non-small cell lung cancer (aNSCLC) patients from ASCO’s CancerLinQ database found that the use of expanded clinical trial inclusion criteria, as proposed by ASCO and Friends of Cancer Research in 2017, would nearly double the percentage of patients eligible to enroll in clinical trials – from 52.3% to 98.5%.
	5.5.9 ASCO (AUTRES ORGANES)
Epizyme Reports Updated Data from Phase 2 Trial of Tazemetostat for Epithelioid Sarcoma at 2019 ASCO Annual Meeting [Epizyme] The epithelioid sarcoma cohort in Epizyme's Phase 2 study represents the largest prospective study of epithelioid sarcoma with any approved or investigational anticancer treatment to date.
ASCO: With FDA review nearing, Epizyme shares updated sarcoma data [Fierce Biotech] Epizyme’s ASCO data featured bigger shifts in the safety data. The rate of grade 3 or higher treatment-emergent adverse events (TEAEs) remained at 13%, but there were increases in TEAEs of all grades.
Bristol-Myers Squibb Announces First Presentation of Results for Opdivo (nivolumab) Plus Yervoy (ipilimumab) Combination in Advanced Hepatocellular Carcinoma at ASCO 2019 [BMS] Opdivo plus Yervoy yielded objective response rate of 31% and median duration of response of 17.5 months.